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Bezlotoxumab (Zinplava®)

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Bezlotoxumab (Zinplava®) Zinplava Swiss Risk Management Plan Summary V1.5 Swiss Summary of the Risk Management Plan (RMP) for Zinplava® (Bezlotoxumab 1000mg) Concentrate for solution for infusion Version 1.5 (November 2016) The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them. The RMP summary of Zinplava® is a concise document and does not claim to be exhaustive. As the RMP is an international document, the summary might differ from the “Arzneimittelinformation / Information sur le médicament” approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorisation. Please note that the reference document which is valid and relevant for the effective and safe use of Zinplava® in Switzerland is the “Arzneimittelinformation / Information sur le médicament” (see www.swissmedicinfo.ch) approved and authorized by Swissmedic. MSD Merck Sharp & Dohme AG is fully responsible for the accuracy and correctness of the content of the published summary RMP of Zinplava®. Zinplava Swiss Risk Management Plan Summary V1.5 1 Elements for Summary Tables in the EPAR 1.1 Summary Table of Safety Concerns Table 1 Summary of Safety Concerns Important identified risks None Important potential risks Infusion-related Reactions Including Hypersensitivity and Anaphylactic Reactions Potential for Immunogenicity Potential Lack of Efficacy if Bezlotoxumab is Administered Off-label as Monotherapy Impaired safety in patients with underlying CHF or with history of CHF Missing information Exposure in Patients <18 years of age Exposure in Pregnancy/Lactation Long Term Safety Repeated Administration of Bezlotoxumab Zinplava Swiss Risk Management Plan Summary V1.5 1.2 Table of Ongoing and Planned Studies in the Post-authorisation Pharmacovigilance Development Plan Table 2 Ongoing and Planned Additional Pharmacovigilance Studies / Activities in the Pharmacovigilance Plan: Imposed Activities, Specific Obligations and Required Activities (Categories 1 - 3) Date for Submission of Safety Concerns Interim / Final Reports Study / Activity Objectives Addressed Status (target dates) (MK-6072-PN001*): Randomised, double- To provide Planned Anticipated Final Report: information on safety Trial in Paediatric blind, single dose, MAR-2019 Patients Aged 24 placebo-controlled trial and efficacy in months to <18 years to evaluate efficacy, patients with CDI who are 24 month to (Category 3) safety, and pharmacokinetics of <18 years of age. Clostridium difficile toxin B human In addition, anti-drug monoclonal antibody antibody (ADA) (MK-6072, assessments will be bezlotoxumab) as add-on conducted to assess to standard of care the potential for antibiotic treatment in immunogenicity. children from 2 to less than 18 years of age with Clostridium difficile infection (CDI). (MK-6072-PN002†): Open label, single dose To provide Planned Anticipated Final Report: information on safety Trial in Paediatric trial to evaluate safety, NOV-2020 Patients Aged <24 tolerability, and and efficacy in months. pharmacokinetics of patients with CDI who are <24 months (Category 3) Clostridium difficile toxin B human of age. monoclonal antibody (MK-6072, In addition, anti-drug bezlotoxumab) in antibody (ADA) children from birth to assessments will be less than 2 years of age conducted to assess with suspected or the potential for documented Clostridium immunogenicity. difficile Infection (CDI), or at risk for developing CDI. * formerly MK-6072 Protocol 015 † formerly MK-6072 Protocol 021 Zinplava Swiss Risk Management Plan Summary V1.5 1.3 Summary of Post-authorisation Efficacy Development Plan Not applicable. Zinplava Swiss Risk Management Plan Summary V1.5 1.4 Summary Table of Risk Minimisation Measures Table 3 Summary of Safety Concerns and Risk Minimisation Activities Additional Risk Minimisation Safety Concern Routine Risk Minimisation Measures Measures Important Potential Risk: SmPC: None Infusion-related Reactions Including Section 4.8 Undesirable effects Hypersensitivity and Anaphylactic Section for Tabulated list of adverse reactions Reactions within Table 1: Adverse Reactions with ZINPLAVA includes infusion related reactions occurring on the day of, or the day after infusion. Section for Description of selected adverse reactions under Infusion Related Reactions states that overall, 10% of subjects in the ZINPLAVA group experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8% in the placebo group. Infusion specific adverse reactions reported in ≥0.5% of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%). Of the patients who experienced an infusion specific adverse reaction, the majority reported a reaction with a maximum intensity of mild (78%) or moderate (20%) and the majority of reactions resolved within 24 hours following onset. Package Leaflet: Section 4 Possible side effects Includes side effects reported in clinical trials as Common: diarrhoea, dizziness, feeling sick (nausea), fever, headache, high blood pressure, shortness of breath, tiredness. Tell your doctor or health care professional if you notice any of the side effects above. Zinplava Swiss Risk Management Plan Summary V1.5 Table 3 Summary of Safety Concerns and Risk Minimisation Activities Additional Risk Minimisation Safety Concern Routine Risk Minimisation Measures Measures Important Potential Risk: SmPC: None Potential for Immunogenicity Section 4.2 Posology and method of administration The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration. 4.4 Special Warnings and precautions for use There is no experience with repeat administration of ZINPLAVA in patients with CDI. In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA. Section 4.8 Undesirable effects Section for Description of selected adverse reactions under Immune-related Adverse Reactions states that in a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks. The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II) in which all patients received a single dose. Section 5.1 Pharmacodynamic properties Section 5.1 under Immunogenicity states that immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II. Following treatment with ZINPLAVA in MODIFY I and MODIFY II, none of the 710 evaluable patients tested positive for treatment- emergent anti-bezlotoxumab antibodies. Although ZINPLAVA is intended for single dose administration, the immunogenicity of bezlotoxumab following a second administration of 10 mg/kg, 12 weeks after the first dose, was assessed in 29 healthy subjects. No anti- bezlotoxumab antibodies were detected after the second dose. There are no data on repeated administration of bezlotoxumab in patients with CDI. Package Leaflet: Not applicable Important Potential Risk: SmPC: None Potential Lack of Efficacy if Section 4. Clinical Particulars Bezlotoxumab is Administered Off- Section 4.1 under Therapeutic indications states label as Monotherapy that ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI. Section 4.2 under Posology and method of administration states that ZINPLAVA should be administered during the course of antibacterial therapy for CDI. Section 4.4 under Special warnings and precautions for use states that ZINPLAVA is not Zinplava Swiss Risk Management Plan Summary V1.5 Table 3 Summary of Safety Concerns and Risk Minimisation Activities Additional Risk Minimisation Safety Concern Routine Risk Minimisation Measures Measures a treatment for CDI and has no effect on the current CDI episode. ZINPLAVA should be administered during the course of antibacterial therapy for CDI. There are no data regarding the efficacy of ZINPLAVA if given after the initial 10 to 14 days of antibacterial therapy for CDI. Package Leaflet: Section 1 What ZINPLAVA is and what is it used for? ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back. How ZINPLAVA works • When people get CDI, they are usually given an antibiotic to get rid of the infection but CDI can often come back within weeks or months. • The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea. • ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back. Section 2 What you need to know before you are given ZINPLAVA under Warnings and precautions ZINPLAVA is not a treatment for CDI. ZINPLAVA has no effect on the CDI you have now. ZINPLAVA is given with the antibiotic therapy you are taking for CDI. Important Potential Risk: Text in Local Swiss Labeling None Impaired safety
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